About

DV-004 is a phase 1b/2 open-label, multicenter study that will enroll participants with LA/mBC that express HER2.

Participants with the following types of breast cancer may be eligible:

  • Cohort A: HER2-low breast cancer
  • Cohort B: HER2-positive breast cancer

Study Design

Arms and Interventions

medications

Cohort A

Population and HER2 Status:
HER2-low LA/mBC

Open-Label Study Treatment
Disitamab vedotin plus tucatinib

medications

Cohort B

Population and HER2 Status:
HER2+ LA/mBC

Open-Label Study Treatment
Disitamab vedotin plus tucatinib

Inclusion Criteria

This is not a complete list of inclusion and exclusion criteria. Please connect with a Principal Investigator for further information.

checklist

General Inclusion criteria

  • Measurable disease according to RECIST v1.1
    • Participants with bone-only metastatic lesions/without target lesion will be excluded
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
checklist

Expansion Phase Cohort A:

  • Histologically or cytologically confirmed diagnosis of breast carcinoma
  • Locally-advanced unresectable, or metastatic stage
  • HER2 status IHC 1+ or higher by most recent local assessment
  • Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies
checklist

Expansion Phase Cohort B:

  • Histologically or cytologically confirmed diagnosis of breast carcinoma
  • Locally-advanced unresectable, or metastatic stage
  • HER2 status (IHC 3+ or IHC 2+/ISH+) by most recent local assessment
  • Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies

Exclusion Criteria

This is not a complete list of inclusion and exclusion criteria. Please connect with a Principal Investigator for further information.

Checklist exclude
  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
  • Prior therapy with ADCs with MMAE payload
  • Prior therapy with tucatinib
  • Active CNS and/or leptomeningeal metastasis
Checklist exclude
  • Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
  • History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
  • Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications
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Primary outcomes

  • Number of participants with dose limiting toxicities (DLTs) in dose escalation phase
  • Number of participants with adverse events (AEs)
  • Number of participants with laboratory abnormalities
  • Number of participants with dose alterations
  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
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Secondary outcomes

  • Duration of response (DOR) per RECIST v1.1 by investigator assessment
  • Disease control rate (DCR) per RECIST v1.1 by investigator assessment
  • Progression free survival (PFS) per RECIST v1.1 by investigator assessment
  • Overall survival (OS) • Pharmacokinetic (PK) parameter – Maximum concentration (Cmax)
  • PK parameter – Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
  • Incidence of anti-drug antibodies (ADAs) against disitamab vedotin

For more information about the DV-004 clinical trial, click here

Get started

Answer a 2-minute questionnaire and speak to a study representative.

A first step as you consider connecting with a Principal Investigator is to answer a 2-minute online questionnaire about your interest and willingness to be contacted. If your answers show the study might be a good fit for you and your patient, you may choose to have your contact information shared with a study clinic that you select for further discussion.

Get connected.

Your answers to these questions will only be linked to you if your responses indicate that you would like to be connected with a Principal Investigator and you choose to share your contact information with the study clinic. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if your patient meets the study’s eligibility criteria and is able to enroll in the study.

 
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Protocol Amendment 21, DV-004 HCP Page, 21Nov24